New suggestions for improving clinical trials during public health emergencies
08 August 2023
In June, the European Medicines Agency's Emergency Task Force (ETF) and the European Commission held a workshop on clinical trials in light of the experiences gathered from the COVID-19-pandemic and the recent outbreak of mpox. The workshop resulted in a number of suggestions to improve large-scale, multinational clinical trials within the EU during public health emergencies.
On 9 June 2023, the ETF and the European Commission held a workshop with participation from stakeholders from Member States, ethical committees, and academic sponsors for the purpose of collecting insights and suggestions for improving the framework for multinational clinical trials during public health emergencies within the EU.
The contents and conclusions from the workshop can be found in a recently published report from EMA. Discussions at the workshop exposed a need for larger studies across multiple European countries, speedier recruitment and delivery of conclusive results with accelerated timelines during future public health emergencies.
The suggestions can be grouped under two main headings:
1) Processing and regulatory approval of large-scale, multinational clinical trials in EU during public health emergencies
These suggestions cover, among other things, an improved coordination between relevant authorities and ethical committees in and across Member States, an improvement of the application and approval processes for clinical trials, and the advancement of the EU Clinical Trials Information System (CTIS).
2) Framework for funding of clinical trials in health emergencies within EU
These suggestions include the establishment of a Coordinating Committee, responsible for supporting the prioritization of trials, creating improved mechanisms for identifying and ranking promising compounds, streamlining EU and Member State funding mechanisms, and harmonizing and improving the processes relating to the contracting of clinical trial sites.
These are currently only suggestions that the EU institutions and Member States may consider implementing. However, the suggestions are interesting as they outline a more efficient and flexible system for large-scale, cross-border clinical trials during future public health emergencies.
Read The EMA's/ETF's report on the workshop
The contents and conclusions from the workshop can be found in a recently published report from EMA. Discussions at the workshop exposed a need for larger studies across multiple European countries, speedier recruitment and delivery of conclusive results with accelerated timelines during future public health emergencies.
The suggestions can be grouped under two main headings:
1) Processing and regulatory approval of large-scale, multinational clinical trials in EU during public health emergencies
These suggestions cover, among other things, an improved coordination between relevant authorities and ethical committees in and across Member States, an improvement of the application and approval processes for clinical trials, and the advancement of the EU Clinical Trials Information System (CTIS).
2) Framework for funding of clinical trials in health emergencies within EU
These suggestions include the establishment of a Coordinating Committee, responsible for supporting the prioritization of trials, creating improved mechanisms for identifying and ranking promising compounds, streamlining EU and Member State funding mechanisms, and harmonizing and improving the processes relating to the contracting of clinical trial sites.
These are currently only suggestions that the EU institutions and Member States may consider implementing. However, the suggestions are interesting as they outline a more efficient and flexible system for large-scale, cross-border clinical trials during future public health emergencies.
Want to know more?
If you wish to know more about the suggestions or the contents of the report, please contact Plesner's Life Science team.Read The EMA's/ETF's report on the workshop
